Label: HEMCALM- horse chestnut, collinsonia canadensis root, hamamelis virginiana root bark/stem bark ointment
- NDC Code(s): 0220-9178-51
- Packager: BOIRON
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated February 16, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
-
PURPOSE
Purpose*
Aesculus hippocastanum 1X HPUS 1.3% ... Reduces swelling and relieves stinging pain associated with external hemorrhoids
Collinsonia canadensis 1X HPUS 1.3% ... Relieves hemorrhoids associated with constipation
Hamamelis virginiana 1X HPUS 1.3% … Relieves burning, itching, and discomfort associated with hemorrhoids
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
- Adults and children 12 years of age and older: When practical, gently cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply HemCalm Ointment externally to the affected area up to 4 times a day.
- Children under 12 years of age: Ask a doctor.
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SPL UNCLASSIFIED SECTION
do not use if glued carton end flaps are open or if tube seal is broken
dispose of 1 year after opening
1 oz (30 g)
Hemorrhoid Relief*
Burning Itching Pain Discomfort
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details. - INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HEMCALM
horse chestnut, collinsonia canadensis root, hamamelis virginiana root bark/stem bark ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-9178 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 1 [hp_X] COLLINSONIA CANADENSIS ROOT (UNII: O2630F3XDR) (COLLINSONIA CANADENSIS ROOT - UNII:O2630F3XDR) COLLINSONIA CANADENSIS ROOT 1 [hp_X] HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT 1 [hp_X] Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-9178-51 30 in 1 TUBE; Type 0: Not a Combination Product 01/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2020 Labeler - BOIRON (282560473) Registrant - BOIRON, INC. (014892269) Establishment Name Address ID/FEI Business Operations BOIRON 282560473 manufacture(0220-9178)
